Immunogenicity of therapeutic proteins can render the product ineffective and potentially dangerous. Investigators need to know what causes immunogenicity and how to identify immunogenic features to enable them to design their product accordingly. This track will showcase cutting-edge approaches for the identification of risk factors and for designing non-immunogenic biotherapeutics.

We have learned a few lessons as to which factors contribute to immunogenicity of different recombinant preparations of Interferon beta (IFNb), such as route and frequency of administration, drug formulation including pegylation, aggregation, affinity of antibody binding and binding site. Also, patients’ characteristics influence immunogenicity outcomes. How these factors contribute to controlling immunogenicity will be discussed.

2:10 New Approach to B and T Epitope Removal from Immunotoxins with Retention of High Cytotoxic Activity

Recombinant Immunotoxins are hybrid proteins that kill cancer cells. RITs have produced complete remissions in over 50% of patients with drug resistant Hairy Cell Leukemia with impaired immune systems, but are less active in patients with normal immunity. I will describe new highly active immunotoxins predicted to have low immunogenicity in humans as a result of experimental approaches for the identification and removal of B and T cell epitopes.

2:40 Immunogenicity Risk Assessment Using Human in silico and in vitro Tools

Noel Smith, Ph.D., Senior Group Leader, Lonza Biologics

Incorporating immunogenicity risk assessment into the early stages of development is important for optimal lead selection. This presentation will focus on the human immunogenicity risk assessment platforms at Lonza to aid the selection and optimization of lead candidates. Platforms include Epibase™ in silico for the prediction of T cell epitopes and Epibase™ in vitro for the assessment of T cell and B cell responses in human donor PBMC.

3:10 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00 Problem Solving Breakout Discussions

These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.